In Vivo Determination & Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant
Sponsor study identifier
observational
66
1 country
2
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Actual (reported)Study Completion
August 2017
Actual (reported)A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA. ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2013
Actual (reported)June 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2013
Actual (reported)July 2017
Actual (reported)August 2017
Actual (reported)Kinematic Patterns during gait
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
at least 6 months post surgery
Kinematic patterns during deep knee bend
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
at least 6 months post surgery
Kinematics patterns during going up and down stairs
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
at least 6 months post surgery
Kinematics patterns during getting up from chair
Patients with ConforMIS implants
Patients implanted with standard total knee implant
iTotal CR by Conformis
A standard knee replacement not using ConforMIS' iFit technology
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard total knee replacement who meets the inclusion/exclusion criteria
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37923, United States
University of Tennessee
Knoxville, Tennessee, 37996, United States
Richard D Komistek, PhD
Univeristy of Tennessee
Harold Cates, MD
Tennessee Orthopaedic Clinics
66 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2013
First Posted
June 20, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
at least 6 months post surgery
Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
August 2017
Actual (reported)Last Updated
October 25, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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